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Publications

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    • All HBS Web  (359)
      • Faculty Publications  (21)

      Drug Trials Remove Drug Trials →

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      Could a New Business Model Make Clinical Drug Trials More Accessible to Patients?
      Could a New Business Model Make Clinical Drug Trials More Accessible to Patients?
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      • 2021
      • Working Paper

      The Health Costs of Cost-Sharing

      By: Amitabh Chandra, Evan Flack and Ziad Obermeyer
      We use the design of Medicare’s prescription drug benefit program to demonstrate three facts about the health consequences of cost-sharing. First, we show that an as-if-random increase of 33.6% in out-of-pocket price (11.0 percentage points (p.p.) change in...  View Details
      Keywords: Cost-sharing; Impact; Health Care and Treatment; Insurance; Health; Consumer Behavior
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      Chandra, Amitabh, Evan Flack, and Ziad Obermeyer. "The Health Costs of Cost-Sharing." NBER Working Paper Series, No. 28439, February 2021.
      • September 2020
      • Case

      Minerva 2004: Discovery

      By: John R. Wells and Benjamin Weinstock
      After nearly five years in operation, Doctor Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Corporation (Minerva), was reflecting on the company’s next steps. In a few short years, she and her small team had managed to develop a nanoparticle process for...  View Details
      Keywords: Entrepreneurship; Financing and Loans; Strategy; Decision Choices and Conditions; Biotechnology Industry
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      Wells, John R., and Benjamin Weinstock. "Minerva 2004: Discovery." Harvard Business School Case 721-389, September 2020.
      • September 2020
      • Case

      Minerva 2020: Clinical Trials

      By: John R. Wells and Benjamin Weinstock
      In March 2020, Dr. Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Inc. (Minerva), was reviewing the first results of human clinical trials for the company’s novel CAR-T drug therapeutic, one of the first ever to target solid cancer tumors. The results...  View Details
      Keywords: Biotechnology; Strategic Decision Making; Entrepreneurship; Health Testing and Trials; Decision Choices and Conditions; Strategy
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      Wells, John R., and Benjamin Weinstock. "Minerva 2020: Clinical Trials." Harvard Business School Case 721-391, September 2020.
      • September–October 2020
      • Article

      The Past, Present, and (Near) Future of Gene Therapy and Gene Editing

      By: Julia Pian, Amitabh Chandra and Ariel Dora Stern
      Emerging gene therapy and gene-editing technologies will have a growing impact on patient lives and health-care delivery. We analyzed a decade of data on clinical trials and venture capital investments to understand the likely trajectory of genetically focused...  View Details
      Keywords: Gene Therapy; Gene Editing; Impact; Health Care and Treatment; Technological Innovation; Health Testing and Trials; Venture Capital; Change
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      Pian, Julia, Amitabh Chandra, and Ariel Dora Stern. "The Past, Present, and (Near) Future of Gene Therapy and Gene Editing." NEJM Catalyst Innovations in Care Delivery 1, no. 5 (September–October 2020).
      • January 2020
      • Article

      The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System

      By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz
      Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has...  View Details
      Keywords: Medical Devices; Health Testing and Trials; Analysis; Sales
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      Monteleone, Peter P., Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry, and Mark J. Pirwitz. "The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System." Journal of Invasive Cardiology 32, no. 1 (January 2020).
      • October 2019
      • Article

      Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations

      By: Derek C. Angus, Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, Steven Arnold, Anna Barker, Donald A. Berry, Marc J. M. Bonten, Mary Brophy, Christopher Butler, Timothy F. Cloughesy, Lennie P. G. Derde, Laura J. Esserman, Ryan Ferguson, Louis Fiore, Sarah C. Gaffey, J. Michael Gaziano, Kathy Giusti, Herman Goossens, Stephane Heritier, Bradley Hyman, Michael Krams, Kay Larholt, Lisa M. LaVange, Philip Lavori, Andrew W. Lo, Alexander J. London, Victoria Manax, Colin McArthur, Genevieve O’Neill, Giovanni Parmigiani, Jane Perlmutter, Elizabeth A. Petzold, Craig Ritchie, Kathryn M. Rowan, Christopher W. Seymour, Nathan I. Shapiro, Diane M. Simeone, Bradley Smith, Bradley Spellberg, Ariel Dora Stern, Lorenzo Trippa, Mark Trusheim, Kert Viele, Patrick Y. Wen and Janet Woodcock
      Researchers, clinicians, policymakers, and patients are increasingly interested in questions about therapeutic interventions that are difficult or costly to answer with traditional, free-standing, parallel-group randomized controlled trials (RCTs). Examples include...  View Details
      Keywords: Adaptive Platform Trials; Health Testing and Trials
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      Angus, Derek C., Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, Steven Arnold, Anna Barker, Donald A. Berry, Marc J. M. Bonten, Mary Brophy, Christopher Butler, Timothy F. Cloughesy, Lennie P. G. Derde, Laura J. Esserman, Ryan Ferguson, Louis Fiore, Sarah C. Gaffey, J. Michael Gaziano, Kathy Giusti, Herman Goossens, Stephane Heritier, Bradley Hyman, Michael Krams, Kay Larholt, Lisa M. LaVange, Philip Lavori, Andrew W. Lo, Alexander J. London, Victoria Manax, Colin McArthur, Genevieve O’Neill, Giovanni Parmigiani, Jane Perlmutter, Elizabeth A. Petzold, Craig Ritchie, Kathryn M. Rowan, Christopher W. Seymour, Nathan I. Shapiro, Diane M. Simeone, Bradley Smith, Bradley Spellberg, Ariel Dora Stern, Lorenzo Trippa, Mark Trusheim, Kert Viele, Patrick Y. Wen, and Janet Woodcock. "Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations." Nature Reviews: Drug Discovery 18, no. 10 (October 2019): 797–807.
      • November 2018
      • Case

      David Hysong and SHEPHERD Therapeutics

      By: Ananth Raman, John Masko and Aldo Sesia
      In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his...  View Details
      Keywords: Cancer; Therapeutics; Drugs; Health Care and Treatment; Business Startups; Product Development; Financing and Loans; Growth and Development Strategy; Problems and Challenges
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      Raman, Ananth, John Masko, and Aldo Sesia. "David Hysong and SHEPHERD Therapeutics." Harvard Business School Case 619-012, November 2018.
      • 2018
      • Chapter

      The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century

      By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
      On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new...  View Details
      Keywords: Health Care and Treatment; Laws and Statutes; Research and Development; Investment; Markets; Monopoly
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      Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018.
      • January 2018
      • Article

      The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

      By: Aaron V. Kaplan and Ariel Dora Stern
      The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of...  View Details
      Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States
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      Kaplan, Aaron V., and Ariel Dora Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
      • November 2017
      • Case

      The 'Wonder Drug' That Killed Babies

      By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble
      In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children...  View Details
      Keywords: Regulation; Business and Government Relations; Business and Community Relations; Business and Stakeholder Relations; Product Marketing; Corporate Social Responsibility and Impact; Business History; Health; Government Legislation; Corporate Accountability; Ethics; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Public Administration Industry; United States; United Kingdom; Australia; Germany; Europe
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      Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
      • September 2017 (Revised January 2018)
      • Case

      Adaptive Platform Trials: The Clinical Trial of the Future?

      By: Ariel D. Stern and Sarah Mehta
      In July 2017, Dr. Brian M. Alexander, president and CEO of the AGILE Research Foundation, was preparing to launch a new type of clinical trial—an adaptive platform trial—to study potential therapies for glioblastoma (GBM), an aggressive form of brain cancer....  View Details
      Keywords: Clinical Trials; Cancer; Adaptive Platform Trials; Platform Trials; Adaptive Trials; Glioblastoma; Health; Health Care and Treatment; Health Testing and Trials; Business Strategy; Innovation Strategy; Health Industry; United States
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      Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future?" Harvard Business School Case 618-025, September 2017. (Revised January 2018.)
      • June 2014 (Revised February 2017)
      • Case

      Kathy Giusti and the Multiple Myeloma Research Foundation

      By: Richard G. Hamermesh, Joshua D. Margolis and Matthew G. Preble
      What do you do when your rising professional career is cut short by an unexpected cancer diagnosis? Kathy Giusti shifted careers, built a new organization that transformed how cancer research is done, and now faces the challenge of sustaining the organization and its...  View Details
      Keywords: Philanthropy; Philanthropy Funding; Entrepreneurship; Health Care; Management Styles; Personalized Medicine; Health Care Outcomes; Cancer; Cancer Care In The U.s.; Personal Care; Leadership; Leading Change; Social Entrepreneurship; Philanthropy and Charitable Giving; Health Care and Treatment; Leadership Style; Management Style; Management Skills; Growth and Development Strategy; Business Strategy; Health; Health Industry; United States; Canada; Spain
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      Hamermesh, Richard G., Joshua D. Margolis, and Matthew G. Preble. "Kathy Giusti and the Multiple Myeloma Research Foundation." Harvard Business School Case 814-026, June 2014. (Revised February 2017.)
      • October 2013
      • Case

      FasterCures: Removing Barriers to Treatments

      By: Richard G. Hamermesh and James Weber

      In mid-2013, as FasterCures celebrated its 10th anniversary as a center of the Milken Institute, Executive Director Margaret Anderson thought about what the organization should do to ensure it had even more impact in its next 10 years. FasterCures was a non-profit...  View Details

      Keywords: Health Care; Health Care Industry; Health Care Policy; Health Services; Healthcare; Healthcare Reform; Healthcare Ventures; Nonprofit; Non-profit Management; Not-for-profit; Incubator; Accelerator; Venture Philanthropy; Medical Services; Medical Solutions; Medical Research; Medical Treatment; Clinical Trials; Drug Reimbursement; Early Stage; Early Stage Research Funding; Early Stage Funding; Milken Institute; Michael Milken; David Baltimore; Partnering For Cures; National Institutes Of Health; Cancer Care In The U.s.; Cancer Care Services; Policy-making; Health Care and Treatment; Health; Health Testing and Trials; Entrepreneurship; Social Entrepreneurship; Nonprofit Organizations; Policy; Health Industry; United States; District of Columbia
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      Hamermesh, Richard G., and James Weber. "FasterCures: Removing Barriers to Treatments." Harvard Business School Case 814-003, October 2013.
      • September 2012 (Revised November 2014)
      • Case

      Cialis Lifecycle Management: Lilly's BPH Dilemma

      By: Elie Ofek and Natalie Kindred
      How should Eli Lilly further develop and market a new indication of its highly successful erectile-dysfunction (ED) drug, Cialis, without confusing Cialis's hard-won brand equity with physicians and patients? With the final stages of clinical trials for the new...  View Details
      Keywords: Product Positioning; Attitudes; Brands and Branding; Pharmaceutical Industry; United States
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      Ofek, Elie, and Natalie Kindred. "Cialis Lifecycle Management: Lilly's BPH Dilemma." Harvard Business School Case 513-005, September 2012. (Revised November 2014.)
      • August 2012 (Revised March 2021)
      • Case

      ABC Pharmaceuticals

      By: Regina E. Herzlinger and Erik R. Sparks
      This case asks students to price a new drug which is in Stage II of its clinical trials. It contains detailed estimates of the time required and costs for all the steps needed to commercialize a drug in the U.S.  View Details
      Keywords: Drug Development; Product Development; Commercialization; Cost; Health Care and Treatment; Outcome or Result; Business Model; Budgets and Budgeting; Earnings Management; Pharmaceutical Industry
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      Herzlinger, Regina E., and Erik R. Sparks. "ABC Pharmaceuticals." Harvard Business School Case 313-041, August 2012. (Revised March 2021.)
      • November 2009 (Revised March 2010)
      • Case

      Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story

      By: Richard G. Hamermesh, Raju Kucherlapati and Rachel Gordon
      In May 2007, Amgen Inc. (Amgen) received disappointing news from the European Medicines Agency (EMEA) that its drug Vectibix, developed to fight metastatic colorectal cancer, had been rejected. This was especially surprising news given that a similar rival drug had...  View Details
      Keywords: Entrepreneurship; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Marketing Strategy; Product Positioning; Genetics; Biotechnology Industry; Europe; United States
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      Hamermesh, Richard G., Raju Kucherlapati, and Rachel Gordon. "Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story." Harvard Business School Case 810-066, November 2009. (Revised March 2010.)
      • January 2006 (Revised July 2006)
      • Case

      Drug Testing in Nigeria (A)

      By: Debora L. Spar
      In 1996, a meningitis epidemic swept across Nigeria. Thousands of children were struck and, lacking appropriate medicine, were liable to die from the disease. Doctors at Pfizer had an antibiotic that could probably save most of these children's lives. The drug was new,...  View Details
      Keywords: Risk and Uncertainty; Health Pandemics; Health Testing and Trials; Developing Countries and Economies; Pharmaceutical Industry; Nigeria
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      Spar, Debora L., and Adam Day. "Drug Testing in Nigeria (A)." Harvard Business School Case 706-033, January 2006. (Revised July 2006.)
      • August 2005 (Revised December 2006)
      • Case

      Procter & Gamble: Electronic Data Capture and Clinical Trial Management

      By: Robert S. Huckman and Mark J. Cotteleer
      Considers whether the management of Procter & Gamble (P&G) Pharmaceuticals should adopt Web-based electronic data capture (EDC) as the default standard for the management of its clinical drug trials. Provides a detailed description of the existing paper-based process...  View Details
      Keywords: Health Testing and Trials; Internet; Information Technology; Adoption; Business Processes; Industry Structures; Technological Innovation; Service Operations; Pharmaceutical Industry; United States
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      Huckman, Robert S., and Mark J. Cotteleer. "Procter & Gamble: Electronic Data Capture and Clinical Trial Management." Harvard Business School Case 606-033, August 2005. (Revised December 2006.)
      • April 2003 (Revised October 2004)
      • Case

      Novartis: The Challenge of Success (A)

      By: Sandra J. Sucher and Stacy McManus
      Preliminary results from Phase 1 clinical trials of a newly developed compound, STI571, showed that 31 out of 31 patients with chronic myelogenous leukemia (CML) had their blood counts return to normal. In the world of oncology, this was unheard of. This was the...  View Details
      Keywords: Decision Making; Health Testing and Trials; Innovation and Invention; Markets; Distribution; Product Development; Production; Problems and Challenges; Research; Research and Development; Complexity; Biotechnology Industry; Pharmaceutical Industry
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      Sucher, Sandra J., and Stacy McManus. "Novartis: The Challenge of Success (A)." Harvard Business School Case 603-043, April 2003. (Revised October 2004.)
      • January 2001 (Revised July 2003)
      • Case

      Pharmacyclics: Financing Research & Development

      By: Malcolm P. Baker, Richard S. Ruback and Aldo Sesia
      Pharmacyclics (NASDAQ: PCYC), a pharmaceutical company that manufactures products that will improve existing therapeutic treatments for cancer, arteriosclerosis, and retinal disease, was considering a $60 million private placement in February 2000. The company had more...  View Details
      Keywords: Valuation; Cash Flow; Financing and Loans; Business Startups; Financial Strategy; Medical Devices and Supplies Industry; Pharmaceutical Industry; Health Industry
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      Baker, Malcolm P., Richard S. Ruback, and Aldo Sesia. "Pharmacyclics: Financing Research & Development." Harvard Business School Case 201-056, January 2001. (Revised July 2003.)
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      Could a New Business Model Make Clinical Drug Trials More Accessible to Patients?
      Could a New Business Model Make Clinical Drug Trials More Accessible to Patients?
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